NCT07135505招募中不适用
The Effect of Early Time-Restricted Eating on Cardiometabolic Health and Circadian Rhythms in Hypertensive Older Adults With Habitual Prolonged Eating Window
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Blood glucose
研究概览
简要总结
The purpose of this study is to find out how early time-restricted eating affects body rhythms and improves cardiometabolic health in older adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consent to participate in the study
- •Men and women ≥ 60 years old
- •Average office systolic BP ≥130 mmHg
- •Self-reported ≥12 hours eating period per day of at least 5 days/week
- •Stable health history over the past 2 months
排除标准
- •Fasting >12 hours per day
- •Actively trying to lose weight by participating in formal weight loss program or significantly restricting calorie intake
- •Have lost ≥ 10 pounds in last 3 months
- •Unable to wake up at a regular time between 6-8 am
- •Perform overnight shift work more than 1day/week on average
- •Resting heart rate of >120 beats per minute, systolic blood pressure > 180 mmHg and/or diastolic blood pressure of > 100 mmHg
- •Have been diagnosed with diabetes
- •On insulin or diabetes medication
- •Unstable angina, heart attack or stroke in the past 3 months
- •Continuous use of supplemental oxygen to manage a chronic pulmonary condition or heart failure
- •Pregnant or breastfeeding
- •Rheumatoid arthritis, Parkinson's disease or currently on dialysis
- •Current diagnosis of a major psychiatric condition that would impair study participation
- •Severe gastrointestinal disease, major gastrointestinal surgery, or active gallstone disease
- •Active treatment for cancer in the past year
- •Taking medications that preclude fasting for 16 hours (e.g. must be taken with food at least 12 hours apart)
研究组 & 干预措施
Intervention
Active Comparator
Early time-restricted eating
干预措施: Early time-restricted eating (Behavioral)
Control
No Intervention
结局指标
主要结局
Blood glucose
时间窗: Baseline and 12 weeks
measured by the continuous glucose monitor
Heart rate variability
时间窗: Baseline and 12 weeks
measured by the Holter monitor
Blood glucose
时间窗: Baseline and 12 weeks
measured by the continuous glucose monitor
Heart rate variability
时间窗: Baseline and 12 weeks
measured by the Holter monitor
Systolic Blood pressure
时间窗: Baseline and 12 weeks
measured by the ambulatory blood pressure monitor
次要结局
未报告次要终点
研究者
Yi Lin
Instructor
University of Alabama at Birmingham
研究点 (1)
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